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EPOS trial: The eff...
EPOS trial: The effect of air filtration through a plasma chamber on the incidence of surgical site infection in orthopaedic surgery: A study protocol of a randomised, double-blind, placebo-controlled trial
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- Persson, A. (author)
- Karolinska Institutet
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- Atroshi, Isam (author)
- Lund University,Lunds universitet,Ortopedi, Lund,Sektion III,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Orthopaedics (Lund),Section III,Department of Clinical Sciences, Lund,Faculty of Medicine,Central Hospital Kristianstad,Lund Univ, Dept Clin Sci, Lund, Sweden.;Hassleholm Kristianstad Hosp, Dept Orthopaed, Kristianstad, Sweden.
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- Tyszkiewicz, T. (author)
- Karolinska Institutet
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- Hailer, Nils (author)
- Uppsala universitet,Uppsala University,Uppsala University Hospital,Ortopedi,Uppsala Univ Hosp, Dept Orthopaed, Uppsala, Sweden.
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- Lazarinis, Stergios, 1971- (author)
- Uppsala universitet,Uppsala University,Uppsala University Hospital,Ortopedi,Uppsala Univ Hosp, Dept Orthopaed, Uppsala, Sweden.
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- Eisler, T. (author)
- Karolinska Institutet Institutionen för kliniska vetenskaper Danderyds sjukhus, Danderyd, Sweden,Karolinska Inst, Inst Klin Vetenskaper Danderyds Sjukhus, Danderyd, Sweden.
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- Brismar, H. (author)
- Karolinska Institutet,Karolinska Institute,Karolinska University Hospital,Karolinska Inst, Dept Clin Sci Intervent & Technol, Huddinge, Sweden.;Karolinska Univ Sjukhuset & Huddinge, Dept Orthopaed & Biotechnol, Huddinge, Sweden.
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- Mukka, Sebastian (author)
- Umeå University,Umeå universitet,Ortopedi,Umeå University Hospital, Umeå, Sweden,Norrland University Hospital,Umeå Univ, Dept Surg & Perioperat Sci, Umeå, Sweden.;Umeå Univ Hosp, Umeå, Sweden.
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- Kernell, P. J. (author)
- GHP Ortho Center Stockholm, Löwenströmska Hospital, Upplands Väsby, Sweden,Löwenströmska Hosp, GHP Ortho Ctr Stockholm, Upplands Väsby, Sweden.
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- Mohaddes, Maziar, 1974 (author)
- Karolinska Institutet,University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för ortopedi,Institute of Clinical Sciences, Department of Orthopaedics,Swedish Hip Arthroplasty Register, Gothenburg, Sweden; Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University Of Gothenburg, Gothenburg, Sweden,Swedish Hip Arthroplasty Register, Gothenburg, Sweden.;Univ Gothenburg, Sahlgrenska Acad, Inst Clin Sci, Dept Orthopaed, Gothenburg, Sweden.
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- Sköldenberg, O. (author)
- Karolinska Institutet,Karolinska Institute,Karolinska Inst, Inst Klin Vetenskaper Danderyds Sjukhus, Danderyd, Sweden.
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- Gordon, M. (author)
- Karolinska Institute,Karolinska Inst, Inst Klin Vetenskaper Danderyds Sjukhus, Danderyd, Sweden.
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(creator_code:org_t)
- 2022-02-03
- 2022
- English.
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In: Bmj Open. - : BMJ. - 2044-6055. ; 12:2
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Abstract
Subject headings
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- Introduction There is controversy regarding the importance of air-transmitted infections for surgical site infections (SSIs) after orthopaedic surgery. Research has been hindered by both the inability in blinding the exposure, and by the need for recruiting large enough cohorts. The aim of this study is to investigate whether using a new form of air purifier using plasma air purification (PAP) in operating rooms (ORs) lowers the SSI rate or not. Methods and analysis Multicentre, double-blind, cluster-randomised, placebo-controlled trial conducted at seven hospitals in 2017-2022. All patients that undergo orthopaedic surgery for minimum 30 min are included. Intervention group: patients operated in OR with PAP devices turned on. Control group: patients operated in OR with PAP devices turned off. Randomisation: each OR will be randomised in periods of 4 weeks, 6 weeks or 8 weeks to either have the devices on or off. Primary outcome: any SSI postoperatively defined as a composite endpoint of any of the following: use of isoxazolylpenicillin, clindamycin or rifampicin for 2 days or more, International Classification of Diseases codes or Nordic Medico-Statistical Committee codes indicating postoperative infection. In a second step, we will perform a chart review on those patients with positive indicators of SSI to further validate the outcome. Secondary outcomes are described in the Methods section. Power: we assume an SSI rate of 2%, an SSI reduction rate of 25% and we need approximately 45 000 patients to attain a power of 80% at a significance level of 0.05. Ethics and dissemination The study is approved by the Swedish Ethical Review Authority. The interim analysis results from the study will be presented only to the researchers involved unless the study thereafter is interrupted for whatever reason. Publication in a medical journal will be presented after inclusion of the last patient. Trial registration number NCT02695368. © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Ortopedi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Orthopaedics (hsv//eng)
Keyword
- adult orthopaedics
- hip
- infection control
- knee
- orthopaedic & trauma surgery
- clindamycin
- isoxazolylpenicillin
- penicillin derivative
- rifampicin
- unclassified drug
- adult
- air and air related phenomena
- air conditioning
- airborne infection
- airborne transmission
- Article
- clinical article
- clinical trial protocol
- controlled study
- double blind procedure
- female
- hospital readmission
- human
- incidence
- infection rate
- International Classification of Diseases
- length of stay
- male
- multicenter study
- orthopedic surgery
- plasma air purification
- prescription
- randomized controlled trial
- reoperation
- room ventilation
- surgical infection
- Sweden
- total hip replacement
- adult orthopaedics
- Surgery
- Orthopaedics
Publication and Content Type
- ref (subject category)
- art (subject category)
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Bmj Open
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- By the author/editor
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Persson, A.
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Atroshi, Isam
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Tyszkiewicz, T.
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Hailer, Nils
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Lazarinis, Sterg ...
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Eisler, T.
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show more...
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Brismar, H.
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Mukka, Sebastian
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Kernell, P. J.
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Mohaddes, Maziar ...
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Sköldenberg, O.
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Gordon, M.
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Surgery
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Infectious Medic ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Orthopaedics
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Bmj Open
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University of Gothenburg
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Umeå University
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Lund University
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Uppsala University
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Karolinska Institutet